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TULIP et MASC : Premiers Usages (TEMPUS)

Primary Purpose

Thoracic Outlet Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Outlet Syndrome focused on measuring suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspicion of Thoracic Outlet Syndrome

Exclusion Criteria:

Non applicable

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspicion of TOS

Arm Description

Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires

Outcomes

Primary Outcome Measures

Feasibility of both questionnaires : percentage of questionnaires correctly completed
Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.

Secondary Outcome Measures

TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Determine the diagnostic performance of each response according to the presence or absence of vascular compression of the arm considered. We evaluate the correlation between each response of TULIP's items and vascular investigation results (positive ultrasound or/and angiography)
MASC : Concording with DASH questionnaire
Correlation coefficient with the DASH questionnaire
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.

Full Information

First Posted
June 23, 2022
Last Updated
September 12, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT05441176
Brief Title
TULIP et MASC : Premiers Usages
Acronym
TEMPUS
Official Title
TULIP et MASC : Premiers Usages
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up. The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.
Detailed Description
Two questionnaires the TULIP and the MASC are submitted (self completion) to patients suspected of TOS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
Keywords
suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with suspicion of TOS
Arm Type
Experimental
Arm Description
Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Scoring of the DASH is performed according to references.
Primary Outcome Measure Information:
Title
Feasibility of both questionnaires : percentage of questionnaires correctly completed
Description
Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Description
Determine the diagnostic performance of each response according to the presence or absence of vascular compression of the arm considered. We evaluate the correlation between each response of TULIP's items and vascular investigation results (positive ultrasound or/and angiography)
Time Frame
1 day
Title
MASC : Concording with DASH questionnaire
Description
Correlation coefficient with the DASH questionnaire
Time Frame
1 day
Title
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Description
Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspicion of Thoracic Outlet Syndrome Exclusion Criteria: Non applicable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne HERSANT, PhD
Phone
(0)241353689
Ext
+33
Email
explovasculaire@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine MAUBOUSSIN
Phone
(0)668047430
Ext
+33
Email
marine.mauboussin@chu-angers.fr
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne HERSANT, PhD
Phone
(0)241353686
Ext
+33
Email
explovasculaire@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Jeanne HERSANT, PhD

12. IPD Sharing Statement

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TULIP et MASC : Premiers Usages

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